Glossary Term
Iterative Prototyping
Definition
Iterative prototyping is a cyclical product development approach where prototypes are designed, tested, evaluated, and refined based on feedback and performance data. This process continues until the final design meets functional, aesthetic, and regulatory requirements. It is widely used in the MedTech industry to ensure high-quality, user-centric products while minimizing risks.
Relevance to the MedTech Industry
Iterative prototyping accelerates innovation, mitigates design risks, and ensures compliance with user needs and regulatory standards. By incorporating continuous feedback, it enhances usability, functionality, and overall product safety, essential for medical devices that impact patient outcomes.
Additional Information & Related Terms
Related Terms
Rapid Prototyping: Quick production of low-fidelity models for initial design evaluations.
Design Controls: Systematic practices ensuring that device designs meet intended use and safety requirements.
Usability Testing: Assessing how effectively and safely users interact with a device.
Risk Management (ISO 14971): Identifying and mitigating risks throughout the product lifecycle.